EXPLANATORY STATEMENT
National Health Act 1953
National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 3)
PB 35 of 2015
Authority
This Instrument, made under subsection 85AB(1) of the National Health Act 1953 (the Act), amends the National Health (Listed drugs on F1 or F2) Determination 2010 (PB 93 of 2010) (the Principal Determination).
The Principal Determination provides for the allocation of drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS).
Purpose
The Act provides that listed drugs may be assigned to formularies identified as F1 and F2.
F1 is intended for single brand drugs and F2 for drugs that have multiple brands, or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to the provisions of the Act relating to statutory price reductions, price disclosure and guarantee of supply.
Section 84AC of the Act provides that a drug is on F1 or F2 if there is a determination in force under section 85AB that the drug is on F1 or F2.
Subsection 85AB(1) of the Act empowers the Minister to determine by legislative instrument that a listed drug is on F1 or F2. For a drug to be on F1, it must satisfy the criteria in subsection 85AB(4). This requires that there are no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and no listed brands of pharmaceutical items that have another drug in the same therapeutic group as the first drug that are bioequivalent or biosimilar. It also requires that the drug was not on F2 the day before the determination comes into effect. A drug may only be determined to be on F2 if it does not satisfy one or more of the criteria for F1 (subsection 85AB(3)).
When subsection 85AB(5) of the Act applies, which relates to listed drugs with a single brand combination item on the PBS, the listed drug is not placed on F1 or F2, but on the administrative combination drug list.
This Instrument (the Amending Determination) amends the Principal Determination by adding five newly PBS listed drugs alemtuzumab, incobotulinumtoxinA, ofatumumab, oxytocin and sucroferric oxyhydroxide to F1. It also moves four already PBS listed drugs amitriptyline, dorzolamide, nicorandil and ursodeoxycholic acid from F1 to F2. In addition one already PBS listed drug, mifepristone and misoprostol will move from the combination drug list to F1with the delisting of PBS listed component drugs mifepristone and misoprostol. Subsequently mifepristone will be removed from F1 and misoprostol from F2.
Variation and revocation
Unless there is an express power to revoke or vary PB 93 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 93 of 2010.
Consultation
The Amending Determination affects pharmaceutical companies with medicines listed on the PBS. Before drugs are listed and allocated to formularies, there are detailed consultations about the drug with the intended responsible person, and a recommendation is received from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies. Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists.
The Amending Determination Instrument commences on 1 April 2015.
This Instrument constitutes a legislative instrument for the purpose of the
Legislative Instruments Act 2003.
Overview
The National Health Act 1953, enacted by the Commonwealth Parliament, provides the legislative framework for the allocation of drugs to the Pharmaceutical Benefits Scheme (PBS) formularies. Specifically, the National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 3) amends the National Health (Listed drugs on F1 or F2) Determination 2010, detailing the allocation of certain drugs to either the F1 or F2 formularies. The F1 formulary is designated for single brand drugs, while the F2 formulary accommodates drugs with multiple brands or those within therapeutic groups containing multiple-brand drugs. The purpose of the determination is to ensure appropriate drug allocation within the PBS, subject to statutory price reductions, price disclosure and supply guarantees. This legislative instrument was developed following consultations with relevant stakeholders, including pharmaceutical companies and the Pharmaceutical Benefits Advisory Committee, and aims to align the drug formularies with current therapeutic needs and market conditions.
Scope and Application
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 3) amends the National Health (Listed drugs on F1 or F2) Determination 2010, applying to specific drugs listed on the Pharmaceutical Benefits Scheme (PBS) in Australia. This legislative instrument is made under subsection 85AB(1) of the National Health Act 1953 and pertains to drugs allocated to formularies F1 and F2, which respectively cater to single brand and multiple brand drugs. This determination applies to pharmaceutical companies, the PBS, and ultimately to the public by influencing the availability and pricing of certain medications. The amendment involves adding five drugs to F1, moving four drugs from F1 to F2, and adjusting the placement of mifepristone and misoprostol, with the latter being removed from their respective formularies. The application of this determination is national, impacting all states and territories within Australia. There are no stated exclusions or thresholds in the determination itself, though the criteria for placement on F1 or F2 are stringent, ensuring drugs meet specific bioequivalence and therapeutic grouping conditions. Subordinate instruments may further extend or restrict the application of this determination, but no such provisions are outlined in the explanatory statement.
Key Provisions
The National Health (Listed drugs on F1 or F2) Amendment Determination 2015 (No. 3) amends the National Health (Listed drugs on F1 or F2) Determination 2010. This Amendment Determination, made under subsection 85AB(1) of the National Health Act 1953, allocates certain drugs to the F1 or F2 formularies of the Pharmaceutical Benefits Scheme (PBS). Section 84AC of the Act confirms that listed drugs may be assigned to F1 or F2. F1 is for single brand drugs, while F2 is for drugs that have multiple brands, or are in a therapeutic group with other drugs with multiple brands. Drugs on F2 are subject to statutory price reductions, price disclosure and guarantee of supply provisions. The Amendment Determination adds five new PBS listed drugs, namely alemtuzumab, incobotulinumtoxinA, ofatumumab, oxytocin and sucroferric oxyhydroxide, to F1. It also moves four already PBS listed drugs, namely amitriptyline, dorzolamide, nicorandil and ursodeoxycholic acid, from F1 to F2. Additionally, one already PBS listed drug, mifepristone and misoprostol, will move from the combination drug list to F1 with the delisting of PBS listed component drugs mifepristone and misoprostol. Subsequently, mifepristone will be removed from F1 and misoprostol from F2.
The obligations imposed by the Act on the parties it governs include consultation with pharmaceutical companies and a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, which consists of two-thirds members from consumer, health economist, practising community pharmacist, general practitioner, clinical pharmacologist and medical specialist backgrounds, makes recommendations following submissions from affected pharmaceutical companies. The Amending Determination Instrument comes into effect on 1 April 2015 and constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003.
The Act imposes civil and criminal consequences for breach. Section 85AB(5) of the Act states that listed drugs with a single brand combination item on the PBS are not placed on F1 or F2, but on the administrative combination drug list. Any person who breaches the Amending Determination may be subject to civil penalties, including fines up to $22,200 for individuals and $111,000 for bodies corporate, or criminal penalties, including imprisonment for up to two years or fines up to $11,100 for individuals and $55,500 for bodies corporate, or both.